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Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma

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ClinicalTrials.gov Identifier: NCT01845038
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug product, when placed in the canaliculus of the eyelid compares to timolol drops for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: OTX-TPa ~4µg/day over 2 mos. with natural tears drops Drug: OTX-TPb ~3µg/day over 3 months with natural tears drops Drug: Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Double-Masked, Multi-Arm Feasibility Study Evaluating the Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension
Study Start Date : April 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: OTX-TPa
OTX-TPa is a hydrogel punctum plug eluting travoprost in sustained release of ~4µg/day over approximately 2 months. For study masking purposes, subjects in this arm will also have natural tears drops administered.
 Drug: OTX-TPa ~4µg/day over 2 mos. with natural tears drops
OTX-TPa is a hydrogel punctum plug eluting travoprost in a sustained release of ~4µg/day over 2 months. Subjects in this arm will also receive natural tears drops.
Experimental: OTX-TPb
OTX-TPb is a hydrogel punctum plug eluting travoprost in sustained release of ~3µg/day over approximately 3 months. For study masking purposes, subjects in this arm will also have natural tears drops administered.
 Drug: OTX-TPb ~3µg/day over 3 months with natural tears drops
OTX-TPb is a hydrogel punctum plug eluting travoprost in a sustained release of ~3µg/day over 3 months. Subjects in this arm will also receive natural tears drops.
Active Comparator: Timolol
Timolol Maleate (0.5%) ophthalmic solution dosed twice daily (BID). For study masking purposes, subjects in this arm will also have a hydrogel punctum plug with no drug placed for approximately 3 months.
 Drug: Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug
Timolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed.


Outcome Measures
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Primary Outcome Measures :
  1. Mean IOP change from baseline [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Visualization of OTX-TP punctum plug by subject [ Time Frame: 90 days ]
    OTX-TP punctum plug contains conjugated fluorescein to serve as a visualization aid through use of a blue light source and yellow filter to confirm product presence daily by subject for 90 days.


Other Outcome Measures:
  1. Best corrected visual acuity [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be greater than or equal to 18 years of age at Screening.
  • Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma.
  • Subject has a mean baseline (Day -7 and Day 0) Hour 0 (T0) untreated IOP of ≥ 24 mm Hg and ≤ 34 mm Hg in each eye, and (T0 + 4h) and (T0 + 8h) IOP of ≥ 22 mm Hg at Baseline Visit 2. Untreated IOP must be ≤ 34 mm Hg in each eye at all time points at both baseline visits.
  • Subject has a BCVA of 0.6 logMAR (20/80 Snellen) or better in each eye as measured using an ETDRS chart.

Exclusion Criteria:

  • Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
  • Punctum size is smaller than 0.4mm or greater than or equal to 1.0mm.
  • Any single IOP in either eye at any time point during the Screening or either Baseline (Day -7/Day 0) Visits of >34 mm Hg.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845038


Locations
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South Africa
Umhlanga Hospital Medical Centre
Durban, South Africa
Sponsors and Collaborators
Ocular Therapeutix, Inc.
More Information
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Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT01845038    
Other Study ID Numbers: OTX-12-003
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2014
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents